WIlliamson News

There were two companies in cities associated with Williamson County that received FDA citations as a result of two inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 100% increase over the number of companies cited in the previous year.

Of the seven citations issued, the most common citation was 'Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been established'.

All of the companies cited were involved in the Devices sector.

Both companies cited should take voluntary actions to correct their managing operations.

The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.

The FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.

Company Name	Area of Business	Inspection Date	Issue Cited
Princeton Medical Group, Inc.	Devices	11/21/2023	Devices that must be directly marked with a unique device identifier
Princeton Medical Group, Inc.	Devices	11/21/2023	Lack of or inadequate complaint procedures
Sleep 8, LLC	Devices	08/04/2023	Lack of Written MDR Procedures
Sleep 8, LLC	Devices	08/04/2023	Design control - no procedures
Sleep 8, LLC	Devices	08/04/2023	Process control procedures, Lack of or inadequate procedures
Sleep 8, LLC	Devices	08/04/2023	Lack of or inadequate procedures
Sleep 8, LLC	Devices	08/04/2023	Lack of or inadequate complaint procedures